Neuroimaging System Receives FDA Clearance

Medical device company Compumedics has received U.S. Food and Drug Administration approval for its brain activity-mapping neuroimaging technology, Orion LifeSpan™ Magnetoencephalography (MEG).

The 510(k) clearance greenlights the MEG single Dewar system that maps brain activity by recording magnetic fields that are generated by the brain’s natural electrical currents. Powered by the CURRY™ neuroimaging platform, Orion LifeSpan offers a dual-helmet system, enabling recordings for both adult and pediatric patients.

In addition, according to company information, the system is vibration-free and vacuum-cooled with zero-loss helium recycling. It also offers real-time video archiving and full cloud integration.

Based on a press statement, this technology, which sells for between $3-4 million, can primarily be applied in the clinical setting for epilepsy and pre-surgical brain function mapping. The Barrow Neurological Institute in Arizona has completed the first installation and first-phase commissioning of the system.